HER2-positive Breast Cancer
Conditions
Keywords
adjuvant therapy, neratinib
Brief summary
Human epidermal growth factor receptor 2 (HER2) positive breast cancer is a molecular subtype with high malignancy and high risk to recurrence and metastasis. After the appearance of anti-HER2 targeted drugs, the prognosis and survival of these patients were greatly improved. In addition to trastuzumab and pertuzumab, the use of tyrosine kinase inhibitor (TKI) can further improve the survival. The evidence of previous adjuvant TKI anti-HER2 therapy was mainly from ExteNET study. However, due to the limitations of the times, ExteNET research is based on the background of only trastuzumab targeted therapy. Nowadays, there is no evidence that trastuzumab combined patuzumab,use of T-DM1, followed by sequential neratinib can still obtain absolute benefits. Therefore, there is no standard for the use of neratinib in current clinical practice. Investigators want to explore, in the real world, the efficacy and safety of sequential use of naratinib in adjuvant therapy.
Detailed description
Investigators retrospectively recuited patients with early HER2 positive breast cancer treated in Peking University People's Hospital center from January 1, 2019 to November 31, 2024, and prospectively recruit same patients from December 1, 2024 to December 31, 2028. To compare the efficacy and safety of sequential use of neratinib. Inclusion Criteria: 1. Patients with HER2 positive breast cancer who were diagnosed by core needle biopsy/operation in Peking University People's hospital; 2. The patients were treated in Peking University People's Hospital and underwent radical resection with hospitalization records; 3. Received standard anti-HER2 neoadjuvant/adjuvant therapy (trastuzumab, trastuzumab combined with pertuzumab, T-DM1) 4. Has signed and agreed to participate in the PKUPH breast disease cohort study. Exclusion Criteria: 1. Lack of clinical and pathological data (such as imaging data and pathological data); 2. Patients with metastatic breast cancer or bilateral breast cancer; 3. Failure to perform radical surgery patients recieved Neratinib for 1 year or not. Primary end point: 5-year invasive dieased free survival
Interventions
DRUGneratinib
neratinib 240mg qd for 1 year
Sponsors
Shu Wang
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* 1\) Patients with HER2 positive breast cancer who were diagnosed by core needle biopsy/operation in Peking University People's hospital; * 2\) The patients were treated in our hospital and underwent radical resection with hospitalization records; * 3\) Received standard anti-HER2 neoadjuvant/adjuvant therapy (trastuzumab, trastuzumab combined with pertuzumab, T-DM1) * 4\) Has signed and agreed to participate in the PKUPH breast disease cohort study.
Exclusion criteria
* 1\) Lack of clinical and pathological data (such as imaging data and pathological data); * 2\) Patients with metastatic breast cancer or bilateral breast cancer; * 3\) Failure to perform radical surgery
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| invasive disease free survival | 5 years | The time from study enrollment to the first occurrence of the following events defined as failure: local recurrence of ipsilateral invasive breast cancer, contralateral invasive breast cancer, distant recurrence or death from any cause. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| disease free survival | 5 years | The time from study enrollment to the first occurrence of the following events defined as failure, including ipsilateral local recurrence, contralateral breast cancer, distant recurrence or death from any cause. |
| distant disease free survival | 5 years | Time from study enrollment to distant recurrence and metastasis |
| breast cancer specific survival | 5 years | Time from study enrollment to death due to breast cancer |
| overall survival | 5 years | Time from study enrollment to death from any cause |
Countries
China
Contacts
Primary Contactyuan peng, doctor
Outcome results
None listed